Evaluation of Immediate Implant Placement In The Esthetic Zone Using the Bone Shielding Concept Versus Dual Zone Therapy

Alveolar Bone Loss Clinical Trial

Official title:

The Bone Shielding Versus Dual Zone Concept in Treating Thin Walled Fresh Extraction Sockets With Immediate Implant Placement Soft and Hard Tissue Changes A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381467
• Other study ID #: AAN.1
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Immediate implant placement has proven to be a successful treatment procedure that is preferred by patients because of being less traumatic, more time-efficient. Nowadays, the main goal of a successful immediate implant treatment has ceased to be gaining stability and osseointegration, but achieving long-term dimensional stability has become the optimal challenge. Various soft tissue and hard tissue augmentation techniques have been investigated in order to maintain the ridge dimensions following extraction and immediate implant placement.

Description:

It has been noted that the different augmentation procedures aid in decreasing the dimensional changes occurring after immediate implant placement in the esthetic zone. Even though immediate implant placement is a predictable procedure, however, labial bone resorption following tooth extraction is inevitable. The available surgical techniques present do not entirely prevent dimensional variations of the peri-implant hard and soft tissues over time. Furthermore, substantial evidence showed that immediate implant placement failed to halt the resorption of the thin buccal bony plate with subsequent gingival recession, particularly in patients with thin gingival phenotype

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult (>18 years) patients having a single non-adjacent hopeless maxillary tooth in the esthetic zone

• type I socket (intact but thin labial plate of bone and intact overlying soft tissues)

• adequate palatal bone

• =3 mm apical bone to engage the immediately placed implants

• optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.

Exclusion Criteria:

• smokers

• pregnant women

• patients with systemic diseases

• periodontal disease, gingival recession

• infected sockets

• periapical pathosis and history of chemotherapy or radiotherapy within the past 2 years.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Immediate Implants

Intervention

Procedure:
• immediate implant placement with The Dual-Zone Therapeutic Concept
After tooth removal, implant placement, bone grafting, and screw retained provisional restoration, the contour of the ridge can change. Using dual zone grafting was claimed to minimize contour change associated with immediate anterior implants. In this technique. The implant should be placed in an optimal 3 dimensional mode . Xenograft, will be used in the gap to graft the bone and tissue zones, . The graft material helps serve as a scaffold to maintain hard- and soft-tissue volume as well as blood clot for initial healing.
• Immediate implant placement with the bone shielding concept
After atraumatic tooth extraction using periotomes and luxators , socket curettage and cleaning simultaneously using an irrigation curette will be performed. Sulcular dissection of the attached tissue close to the socket orifice incisal and apically will be done using periotome to create a tunnel via the socket orifice. Dental implant will be placed. complete access of the labial plate of bone where all the regenerative materials will be performed to have the bone sheild delivered. A membrane will be inserted to the labial tunnel and tacked using 2 membrane tacks.

Locations

Country	Name	City	State
Egypt	ElAskary dental center	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pink Esthetic Score	Pink Esthetic Score 1-14 score PES	6 months
Secondary	labial bone thickness	radiographic CBCT	6 months
Secondary	Peri-implant probing depth	mm	6 months
Secondary	Implant failure	yes/No	6 months